QFR — Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties Class II
Classification Details
- Product Code
- QFR
- Device Class
- Class II
- Regulation Number
- 864.5430
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Definition
A coagulation system for the measurement of whole blood viscoelastic properties is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in patients.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251404 | hemosonics | Quantra QStat Cartridge | August 25, 2025 |
| K240045 | hemosonics | QStat Cartridge | March 27, 2024 |
| K232215 | hemosonics | Quantra Hemostasis Analyzer | August 24, 2023 |
| K230461 | hemosonics | Quantra Hemostasis Analyzer | March 24, 2023 |
| K223433 | hemosonics | Quantra QPlus System | December 13, 2022 |
| K213917 | hemosonics | QStat Cartridge | November 29, 2022 |
| K201513 | hemosonics | Quantra QPlus System | August 21, 2020 |
| DEN180017 | hemosonics | Quantra Hemostasis Analyzer, QPlus Cartridge | March 12, 2019 |